In February 2010, Medtronic had received 62 reports (out of approximately 110,000 devices worldwide) indicating that the battery voltage at device interrogation was lower than the battery voltage that is tracked by the device to provide data for the elective replacement indicator (ERI) notification.

Medtronic’s investigation found that none of these reports resulted in loss of therapy. Importantly, the original ERI notification, which uses the nightly battery voltage measurement, was unaffected and accurate. Medtronic identified the root cause as higher than expected battery impedance.

Medtronic’s internal testing showed there was no current risk for compromised therapy delivery. If the software update referenced above is not implemented, there will be a potential risk of loss of device functionality in a small percent (less than 0.08% 6 years post-implant) of devices. The software update obviates this risk.

Second Issue

Through internal accelerated testing, Medtronic identified a second issue that projects battery voltage could decrease sooner than expected due to a slightly increased rate of lithium depletion near end of device life. This issue has not been clinically observed and is not expected to occur until approximately 9 years post-implant. If the software update referenced above is not implemented, there may be a potential risk for loss of therapy at or near ERI in a small number of devices. The software eliminates this issue by changing ERI criteria.

Software Update (As of October 2010)

The battery issues described above and subsequent software update are summarized in the table below. When a device receives the software update, if battery impedance is greater than the new ERI threshold ERI will be triggered shortly thereafter. Therefore, clinicians may observe an ERI/EOL indicator at the next patient follow-up. When ERI is triggered by battery impedance, additional battery capacity remains and can support device function at ERI parameters for at least one year. Medtronic is not aware of any reports of loss of therapy due to this issue.

As a reminder, when ERI is triggered, EnRhythm devices revert to VVI pacing at 65 ppm at the programmed output settings. EOL is declared 90 days after ERI or at a battery voltage of 2.69V, whichever comes sooner.

Battery Issue

Software Update

Battery voltage could decrease sooner that expected due to a slightly increased rate of lithium depletion

Changed ERI battery voltage threshold from 2.59V to 2.81V to ensure 90 days of therapy from ERI to EOL

Higher than expected battery impedance

Added a secondary ERI trigger based on battery impedance. This new criteria will identify devices with increased battery impedance before device performance is impacted.

We now have access to battery impedance and ERI performance on more than 5000 EnRhythm devices that have received the EnRhythm software update. Our modeling based on these data shows that approximately 6-10% of devices will reach ERI within 5 years post-implant. Consistent with our previous communications, we continue to expect average device longevity to be reduced by approximately 10 –15%, with the expected average longevity remaining at 8.5 to 10.5 years, depending on device settings.1

Updated Patient Management Recommendations (as of August 2011)

After consultation with Medtronic’s Independent Physician Quality Panel, we recommend:

Performing a device follow-up within 90 days after the software download to identify devices that triggered ERI shortly after the software update. Subsequent follow up can be performed per standard practice. During programmer interrogation of a device at ERI, there is a slight possibility a transient drop in pacing amplitude could occur. If this is noted, either remove the programmer head or temporarily program to a higher output voltage.

If an unanticipated ERI/EOL is declared, it is likely due to battery impedance. In such cases, additional battery capacity remains and can support device function at ERI parameters for at least one year. However, when ERI or EOL (typically 90 days after ERI) declaration is seen, schedule device replacement.

Status Update

First Issue

Included in the August 2011 Performance Update was information about the projected percentage of devices that would encounter an early ERI due to unexpected high battery impedance. As of March 6, 2017, the percentage of devices that encountered ERI due to battery impedance has not exceeded the rate of 6-10% within 5 years of post-implant as communicated with our August 2011 Performance Update. Only devices using the updated software can trigger ERI due to impedance. Over 98% of the remaining active population is over 5 years post-implant.

Initial Affected Population

Number of Confirmed ERIs due to impedance

Number of Confirmed ERIs due to impedance within 5 years post-implant

Estimated ERI rate due to impedance within 5 years post-implant2

Confirmed events of loss of therapy due to battery impedance

Estimated Remaining Active Population

All EnRhythm pacemakers (146,500 Worldwide)

17,801 Worldwide

5,898

6.4%

0

36,500 Worldwide

Second Issue

Initial Affected Population

Number of Events of Loss of Therapy Due to Increased Rate of Lithium Depletion

Estimated Remaining Active Population

All EnRhythm pacemakers (146,500 Worldwide)

0 Worldwide

36,500 Worldwide

1The 8.5 year estimate represents a high use scenario (DDD, 100% pacing in atrium and ventricle with 3.0 V output in both chambers). The 10.5 year estimate represents a typical use scenario for a sinus node dysfunction patient with the MVP function ON (AAI(R) <=> DDD(R), 50% pacing in atrium and 5% pacing in ventricle with 3.0 V output in both chambers). Projections are based on modeling and not actual field returns, due to limited availability of implant experience beyond 6 years. Field performance will continue to be monitored and modeling updated to reflect actual data.

2Accounts for underreporting of impedance ERIs based on the fraction of replaced devices in the U.S. registration system that are subsequently returned.